Media Coverage
Process Development And Scale-up For APIs
December 1, 2009
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Ash Stevens, Inc has begun a $6 million expansion of its manufacturing facility, with further phases planned to occur over the next six years, allowing the company to offer a range of process development, scale-up and manufacturing options for APIs.
Headquartered in Detroit, Michigan, USA, Ash Stevens, Inc. (ASI) was founded in 1962 to service the chemical research needs of the US Federal Government. The company has extensive experience in the process development and scale-up of commercial cancer APIs and has a longstanding relationship with the US National Cancer Institute. ASI has a total of 11 FDA-approved drug substances in its portfolio, employs more than 60 people, and holds a variety of patents ranging from medicinal agents to manufacturing processes.
As an established contractor, ASI has been conducting process development and manufacturing of APIs in Michigan since the 1960s, and has developed substantial expertise in high-potency active pharmaceutical ingredients (HPAPIs), including cancer drugs. Over the past five years, ASI has invested more than $15 million in its manufacturing facility located in Riverview, Michigan. These improvements have expanded the company’s capabilities while integrating new technology to create safe product development and manufacturing processes. In addition, ASI has diversified its customer base while growing science-related jobs in Michigan.
Multi-year expansion project
The company recently announced that it is in the initial phases of a multi-year expansion project to upgrade its capacity and capabilities at its Riverview facility. ASI is investing more than $6 million for the initial phases of the expansion, which include a new reactor bay and warehouse. Dr Stephen Munk, ASI’s president & CEO, says the investment will add significant capacity and additional capabilities to its existing facility as part of its on-going commitment to provide the company’s clients with the highest quality service, safety, and on-time delivery of APIs.
The new manufacturing facilities will be operational in January 2010. The isolated reactor bay will house two 100-gallon glass-lined reactors and a 50-gallon hydrogenation vessel, and will also provide redundant capacity to a similarly designed existing bay that holds three 100-gallon reactors, as well as additional plant capacity and plant-scale hydrogenation capabilities. Later in the year, in June, ASI will occupy a new 10,000 square foot warehouse facility. Dr. Munk says completion of the state-of-the-art reactor bay and warehouse facility will set the stage for the execution of the next phases of the expansion plan:
“The new bay and warehouse represent a self-financed $6 million investment for ASI,” he says. “The continuous upgrading and modernisation of our operations is an essential component of our business model to provide our clients the highest quality service while ensuring delivery of their API on time and on schedule from a safe and environmentally friendly facility. As we increase our efficiencies with larger equipment, we also enhance our cost-effectiveness, further benefiting our customers.”
Later phases of the expansion plan include a new large-scale reactor bay, process development laboratories, and additional facilities for handling highly potent APIs.
New capabilities
These new developments follow on from ASI’s investments earlier this year in parallel synthesis and calorimetry instrumentation at the Riverview facility, designed to enhance the speed and safety of scale-up. This new equipment gives the company’s process development chemists the ability to assess heats of reaction for the safe scale-up of industrial processes. The system captures real-time data and provides electronic records useful for post-experiment analysis. “Traditionally, an experienced scientist could conduct two concurrent experiments manually in the laboratory. With the new system, up to four experiments can be conducted simultaneously spanning a broad range of conditions,” says Dr. Munk. The new safety enhancements also include a Thermal Screening Unit used to evaluate the onset of thermal decomposition of reaction components.
“These investments allow us to rapidly optimise chemical processes and better understand process safety parameters prior to scale-up,” he adds. “Our customers will benefit from increased time savings.”
ASI’s success has not gone unnoticed: having recorded a 2008 revenue increase of 50 per cent over the previous year, the company was ranked seventh on Crain’s Detroit Business list of top Detroit-area biotech companies. Dr. Munk attributes this success and sustained growth primarily to client focus:
“To be successful, we have to share the same goals as our clients, be proactive in looking out for our client’s interests, and be flexible in adapting to our client’s needs,” he says. “Our strong base of repeat business from clients who have worked with us in the past is evidence of our commitment to doing quality work, delivering on goals, and client satisfaction.”
Compliance with ChemStewards
ASI’s commitment to quality is demonstrated by the company’s completion last January of the requirements for SOCMA’s ChemStewards® programme and its subsequent certification of compliance with ChemStewards. The programme is SOCMA’s flagship environmental, health, safety and security (EHS&S) continuous performance improvement programme, and was created from industry’s commitment to reducing the environmental footprint left by member’s facilities. The fine and speciality chemical industry created ChemStewards to meet its special needs and is a mandatory requirement for SOCMA members engaged in the manufacturing or handling of synthetic and organic chemicals.
“ChemStewards certification sends a strong message to our employees and our community that Ash Stevens is committed to a safe and environmentally friendly operation,” says Dr. Munk. “It gives our customers the assurance that we are committed to compliance with all applicable federal EHS&S regulations at our facility.”
Amid a struggling Michigan economy, Dr. Munk points out that one bright spot is the biosciences community, which enjoys strong support from the state of Michigan. Earlier this year, Michigan became one of the few states with legislative biotech initiatives in both the house and senate. State legislators agreed to form a senate task force on biotechnology and a house subcommittee on biosciences to grow resources for Michigan’s biotech industry.
The private sector in the state is also working towards a more robust biotech industry, as ASI and seven other drug development contract service providers have recently formed the Michigan CMC Alliance, which provides chemistry, manufacturing and controls resources and strategies to life science companies.
The Michigan-CMC Alliance is comprised of an informal association of Life Science Companies providing complementary contract drug development and manufacturing services that span the pharmaceutical CMC development universe. The scaling down of large pharmaceutical operations in the state of Michigan spawned a number of start-up Life Science contract and consultancy service companies in the state piloted and staffed by talented and seasoned pharmaceutical professionals. Synergies between various service companies in the state that include the long-time established contract pharmaceutical manufacturer Ash Stevens, Inc. provide a unique opportunity to offer a continuum of CMC services through interactive but individual expert service companies in one general location.
“By tapping into this support network, emerging contract companies don’t have to develop this expertise internally, thereby saving costs and ensuring flexibility that is especially critical during this weak economy,” said Dr. Munk. Because of the companies’ good working relationships and proximity, clients can always rely on quality service from members of the CMC Alliance.
“The CMC alliance benefits the biotech community by providing support for the growth and success of life science companies. ASI’s involvement in the CMC alliance ensures that clients will have access to cGMP API manufacturing expertise.
The eight companies representing the Michigan CMC Alliance include: Ash Stevens, Inc., providing GMP API development and manufacturing; BioSTAT Consultants, offering statistical services including design and analysis; Eurofins AvTech Laboratories, Inc., providing GMP and GLP analytical services; Global Clinical Connections, LLC, providing clinical supplies management; Pharmaceutical Development Consulting, LLC, a provider of formulation development and project management; PharmaMed Resources, LLC specialised in quality assurance; ProReg Resources, LLC, a provider of regulatory consulting services; and Velesco Pharmaceutical Services, which offers formulation and analytical development in GMP manufacturing.
Further Information
Dr Stephen A. Munk
Ash Stevens Inc
5861 John C. Lodge Freeway
Detroit, MI 48202
USA
Tel: +1 313 872 3621
Fax: +1 313 872 6841
Internet Links:
Email: samunk@ashstevens.com
Web: www.ashstevens.com